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Monoclonal Antibodies

Batoclimab for CIDP

Phase 2
Recruiting
Research Sponsored by Immunovant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 12) and up to week 36

Summary

This trial tests a drug to treat CIDP, an immune disorder; it includes screening, treatment, and follow-up phases lasting up to 104 weeks. Eligible participants are assigned to one of three cohorts.

Who is the study for?
Adults over 18 with active Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who meet specific diagnostic criteria can join this trial. They should not have other types of polyneuropathies, IgM paraproteinemia, certain forms of CIDP like Distal or Sensory CIDP, poorly controlled diabetes, central demyelination signs, or be on high doses of corticosteroids.
What is being tested?
The study tests Batoclimab's effectiveness and safety in treating CIDP. Participants will receive either Batoclimab at two different dosages or a placebo via subcutaneous injections for up to one year with various periods including washout and long-term extension phases.
What are the potential side effects?
While the side effects are not explicitly listed here, participants may experience reactions related to subcutaneous injections such as pain at the injection site, redness, swelling, and potential immune-related responses due to the nature of Batoclimab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 12) and up to week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 12) and up to week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Period 2, Cohort A: Proportion of participants who remain relapse-free at Week 36
Secondary study objectives
Period 2, Cohort A: Change from Period 2 Baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS)
Period 2, Cohort A: Change from Period 2 Baseline in Mean grip strength
Period 2, Cohort A: Change from Period 2 Baseline in Medical Research Council (MRC) Sum Score
+1 more

Trial Design

18Treatment groups
Experimental Treatment
Group I: Withdrawal Period 2: Cohort D, PlaceboExperimental Treatment1 Intervention
Group II: Withdrawal Period 2: Cohort D, Dose 2Experimental Treatment1 Intervention
Group III: Withdrawal Period 2: Cohort C, PlaceboExperimental Treatment1 Intervention
Group IV: Withdrawal Period 2: Cohort C, Dose 2Experimental Treatment2 Interventions
Group V: Withdrawal Period 2: Cohort B, PlaceboExperimental Treatment1 Intervention
Group VI: Withdrawal Period 2: Cohort B, Dose 2Experimental Treatment2 Interventions
Group VII: Withdrawal Period 2: Cohort A, PlaceboExperimental Treatment1 Intervention
Group VIII: Withdrawal Period 2: Cohort A, Dose 2Experimental Treatment2 Interventions
Group IX: Treatment Period 1: Cohort D, Dose 2Experimental Treatment1 Intervention
Group X: Treatment Period 1: Cohort D, Dose 1Experimental Treatment1 Intervention
Group XI: Treatment Period 1: Cohort C, Dose 2Experimental Treatment1 Intervention
Group XII: Treatment Period 1: Cohort C, Dose 1Experimental Treatment1 Intervention
Group XIII: Treatment Period 1: Cohort B, Dose 2Experimental Treatment1 Intervention
Group XIV: Treatment Period 1: Cohort B, Dose 1Experimental Treatment1 Intervention
Group XV: Treatment Period 1: Cohort A, Dose 2Experimental Treatment1 Intervention
Group XVI: Treatment Period 1: Cohort A, Dose 1Experimental Treatment1 Intervention
Group XVII: LTE Period: Without Relapse in Period 2: Dose 2Experimental Treatment1 Intervention
Participants will receive Dose 2 for all 52 weeks.
Group XVIII: LTE Period: With Relapse in Period 2: Dose 1 and Dose 2Experimental Treatment2 Interventions
Participants will receive Dose 1 for the initial 4 weeks only and Dose 2 for the remaining 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Immunovant Sciences GmbHLead Sponsor
9 Previous Clinical Trials
759 Total Patients Enrolled

Media Library

Batoclimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05581199 — Phase 2
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Research Study Groups: Treatment Period 1: Cohort D, Dose 1, LTE Period: With Relapse in Period 2: Dose 1 and Dose 2, Withdrawal Period 2: Cohort A, Placebo, Withdrawal Period 2: Cohort B, Placebo, Treatment Period 1: Cohort A, Dose 2, Treatment Period 1: Cohort D, Dose 2, Withdrawal Period 2: Cohort C, Placebo, Withdrawal Period 2: Cohort D, Dose 2, Withdrawal Period 2: Cohort D, Placebo, LTE Period: Without Relapse in Period 2: Dose 2, Treatment Period 1: Cohort A, Dose 1, Treatment Period 1: Cohort B, Dose 1, Treatment Period 1: Cohort B, Dose 2, Treatment Period 1: Cohort C, Dose 1, Treatment Period 1: Cohort C, Dose 2, Withdrawal Period 2: Cohort A, Dose 2, Withdrawal Period 2: Cohort B, Dose 2, Withdrawal Period 2: Cohort C, Dose 2
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Clinical Trial 2023: Batoclimab Highlights & Side Effects. Trial Name: NCT05581199 — Phase 2
Batoclimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05581199 — Phase 2
~100 spots leftby Jan 2026
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